- The Harmonic™ clinical trial, a Phase 2 study in never-smoker
patients with non-small lung cancer, has activated 5 clinical trial
sites, across 12 locations, and anticipates multiple additional
sites in the US during the 1st half of 2023; first enrolled
patients are anticipated for Q2 2023.
- IND-enabling studies for LP-184 are completed, and submission
of the IND application to the FDA is anticipated for April
2023.
- Completion of IND-enabling studies for LP-284 and submission of
the IND application to the FDA are anticipated in mid-2023.
- First-in-human Phase 1 clinical trials for LP-184, in
genomically defined solid tumors, and for LP-284, in multiple
non-Hodgkin’s lymphomas, are targeted for launch in mid-2023.
- Starlight Therapeutics Inc., a wholly-owned Lantern subsidiary,
was formed to focus exclusively on the clinical development of
therapies for multiple CNS (central nervous system) and brain
cancers; clinical trials for lead drug candidate, STAR-001, in CNS
cancers are anticipated for late 2023/early 2024.
- RADR®, Lantern’s oncology-focused AI drug development platform,
surpassed 25 billion oncology-focused datapoints; future
advancements will include AI-driven insights for the development of
combination regimens, including immuno-oncology agents, and for the
development of antibody drug conjugates (ADCs).
- $55.2 million in cash, cash equivalents, and marketable
securities as of December 31, 2022.
- Lantern has a cash runway into 2025.
- Conference call scheduled for 4:30 p.m. ET / 1:30 p.m. PT
today.
Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage
biopharmaceutical company using its proprietary RADR® artificial
intelligence ("AI") and machine learning (“ML”) platform to
transform the cost, pace, and timeline of oncology drug discovery
and development, today announced operational highlights and
financial results for the fourth quarter and fiscal year ended
December 31, 2022.
“The Lantern team spent 2022 focused on preparing our unique
drug candidates, LP-184 and LP-284, for the clinic, while at the
same time advancing the clinical foundation and infrastructure for
our Phase 2 Harmonic™ clinical trial for never-smokers with NSCLC.
We have been working relentlessly towards the objective of leading
the transformation of our industry’s approach to the pace, risk,
and cost of drug development by leveraging large scale data,
machine learning, and leading-edge artificial intelligence
technologies. We believe our capabilities in the development of
precision oncology medicines and ADCs will establish us as a
pioneer in the field of AI-based drug discovery,” commented Panna
Sharma, CEO and President of Lantern Pharma.
“During 2022 we also made significant advances in the field of
CNS oncology, which resulted in several new indications for our
drug candidate LP-184. We have gone from one CNS indication, GBM,
to seven indications in less than 18 months and in a highly capital
efficient manner. This unique achievement would have only been
possible by combining our AI-driven approach along with our
collaborative business model, where we engage with top-tier
researchers and institutions to both validate and sharpen our
development plans for specific cancer subtypes and patient
populations. In 2023, we expect to launch multiple first-in-human
clinical trials in targeted cancers, where there is an urgent
patient need and clear evidence from both our in-silico and in-vivo
studies of the potential to improve outcomes for patients.
Ultimately, we believe that this will help to create significant
value for investors and for the broader community of precision
oncology,” continued Sharma.
Portfolio Highlights:
- LP-184 – The investigational new drug (IND) enabling
studies for LP-184 have been completed and the submission of the
IND application to the US Food and Drug Administration (FDA) is
anticipated during Q2 2023. Lantern is anticipating a Phase 1A
basket trial for LP-184 in 2023, for recurrent brain cancers,
including glioblastoma (GBM), brain metastases and other central
nervous system (CNS) cancers, pancreatic cancer, and additional
solid tumors with DNA damage response (DDR) deficiencies. Globally,
the aggregate annual market potential of these programs is
estimated to be approximately $11.0-13.0 billion, consisting of
$5.0-6.0 billion for CNS cancers and $6.0-7.0 billion for solid
tumors. At the 2022 San Antonio Breast Cancer Symposium (SABCS),
Lantern scientists presented new research on the anti-tumor
potential of LP-184 for Triple Negative Breast Cancer (TNBC), one
of the most malignant forms of breast cancer. The presentation
highlighted results demonstrating that LP-184 treatment of 10 TNBC
patient-derived xenograft (PDX) mouse models, led to complete and
durable tumor regression of 107-141%. In addition to primary TNBC
tumors, LP-184 may also have added therapeutic potential to treat
brain metastases (brain mets.) from TNBCs, which are found in ~14%
of TNBC patients at their initial diagnosis. In the US, there are
approximately 28,000 newly diagnosed and relapsed TNBC patients per
year, representing an estimated annual market potential of up to
$1.7 billion.
- LP-300 – Harmonic™ is a Phase 2 clinical trial for
never-smoker patients with relapsed non-small cell lung cancer
(NSCLC) and will assess the effect of LP-300 in combination with
standard-of-care chemotherapy, pemetrexed and carboplatin, on
patient overall and progression-free survival. Lantern has
activated 5 clinical trial sites at 12 different locations across
the US, including Gabrail Cancer Center, Northwest Oncology, New
York Cancer and Blood Specialists, Texas Oncology, and Cancer and
Blood Specialty Clinic. Across the 5 Harmonic™ clinical trial
sites, there is 1 consented patient that is anticipated to be dosed
in Q1 2023 and 14 additional potential patients that have been
pre-screened and are being monitored for possible enrollment.
Multiple additional trial sites across the US are expected to be
activated in the 1st half of 2023 and will bolster patient
recruitment and enrollment. In the US, there are approximately
20,000-40,000 never-smokers with NSCLC diagnosed annually,
representing an estimated annual market potential of $1.5-2.0
billion. Additional information on the Harmonic™ trial can be found
at the Harmonic™ website and the clinicaltrials.gov website. This
quarter, Lantern launched a first-of-its-kind iPhone app for the
Harmonic™ clinical trial. The Harmonic™ app provides patients,
caregivers, and the healthcare community with mobile access to
up-to-date information on the Harmonic™ trial, including how NSCLC
is different in never-smokers versus in tobacco users, what taking
part in the Harmonic™ trial involves, the ability to contact the
Harmonic™ clinical trial team, information on LP-300, and the
locations of all currently active clinical trial sites. Download
the Harmonic™ clinical trial app here.
- LP-284 – The completion of the LP-284 IND enabling
studies and submission of the IND application to the US FDA are
anticipated in mid-2023. A first-in-human Phase 1 clinical trial
launch is anticipated in 2023 for B-cell non-Hodgkin’s lymphomas
(NHL), where LP-284 has shown nanomolar potency across multiple in
vitro and in vivo studies, including mantle cell lymphoma (MCL),
double hit lymphoma (DHL), and other NHL cancer subtypes. Nearly
all MCL patients relapse from the MCL standard-of-care agents
Bortezomib and Ibrutinib and there is an urgent and unmet need for
novel improved therapeutic options for these patients. In the US
and Europe, MCL and DHL are diagnosed in approximately 9,000
patients each year and have an estimated annual market potential of
$1.2 billion. In January 2023, the U.S. Food and Drug
Administration (FDA) granted LP-284 an Orphan Drug Designation
(ODD) for the treatment of MCL, based on LP-284’s demonstrated
anti-tumor activity across a comprehensive number of in vitro and
in vivo models of mantle cell lymphoma (MCL). The ODD strengthens
LP-284’s clinical development path and provides the future
potential opportunity for additional market exclusivity and
commercial protection. In addition to the ODD granted for LP-284 in
MCL, Lantern was previously granted ODDs by the FDA for its drug
candidate LP-184 for the treatment of malignant gliomas, ATRT, and
pancreatic cancer. Lantern has also been granted a Rare Pediatric
Disease Designation for LP-184 in ATRT. At the 2022 American
Society of Hematology (ASH) annual meeting, Lantern scientists
presented new research on LP-284 for MCLs. The poster presentation
featured results demonstrating that LP-284 treatment had between
91-105% greater tumor growth inhibition (TGI) in mice implanted
with MCL cell-derived xenograft (CDX) tumors, when compared to
treatment with current MCL therapies Ibrutinib or Bortezomib.
- LP-100 – In LP-100’s previous Phase 2 trial in Denmark
for patients with metastatic castration resistant prostate cancer
(mCRPC), the initial cohort of nine patients (out of a targeted
enrollment of 27) experienced a median overall survival of 12.5
months, which is an improvement over other similar fourth-line
treatment regimens for mCRPC. Based on Lantern’s recent in silico
and in vivo results demonstrating the synergies of LP-100 with PARP
inhibitors (PARPi), and the industry’s development of entirely new
classes of radio-ligand based therapy for mCRPC, the decision has
been made to close the Phase 2 clinical trial in Denmark. Lantern
believes that the strong anti-cancer synergy between LP-100 and
PARPis will allow this drug combination to be positioned in earlier
lines of therapy for treatment indications with larger market
sizes. Potential treatment indications for LP-100 and PARPi
combination therapy may include homologous recombination repair
(HRR) gene-mutated metastatic castration-resistant prostate cancer,
first line platinum-responsive advanced ovarian cancer, and
BRCA-mutated metastatic breast cancer. The total U.S. market size
of these and other potential target development indications for the
LP-100 and PARPi combination is estimated at between $700 million
and $2 billion.
Formation of Starlight Therapeutics:
Lantern recently formed a wholly-owned subsidiary, Starlight
Therapeutics Inc. (“Starlight”), to develop drug candidate LP-184’s
central nervous system (CNS) and brain cancer indications –
including glioblastoma (GBM), brain metastases (brain mets.), and
several rare pediatric CNS cancers. Starlight will refer to the
molecule LP-184, as it is developed in CNS indications, as
“STAR-001”.
The programs being developed by Starlight were born from the
analysis of billions of oncology-focused data points and by using
Lantern’s AI platform, RADR®. STAR-001’s powerful anti-tumor
mechanism of action, synthetic lethality, and collaborations with
internationally recognized institutions, including the Kennedy
Krieger Institute at Johns Hopkins and the Greehey Children’s
Cancer Research Institute at UT Health – San Antonio, make it well
positioned to advance in targeted and efficient clinical
development programs. Starlight intends to pursue human clinical
trials for multiple CNS indications starting in late 2023, building
on prior IND-enabling studies and the upcoming Phase 1A clinical
testing that will be conducted by Lantern.
The clinical development of STAR-001 in CNS cancers beyond the
Phase 1A trial will be conducted exclusively by Starlight.
Following the launch of Starlight, Lantern will continue to advance
LP-184’s preclinical and clinical development for non-CNS
indications (including pancreatic cancer and other solid tumors)
and will also provide AI-driven bioinformatic and computational
biology support to Starlight.
“The formation of Starlight as a wholly-owned subsidiary allows
Lantern to sharpen the focus on advancing STAR-001 through targeted
clinical trials and dedicate increased time, resources, and
personnel to progress one of the most promising drug candidates for
CNS cancer patients in decades,” stated Panna Sharma, Lantern’s CEO
and President. “We believe that by focusing our efforts via
Starlight Therapeutics we can accelerate and deepen our commitment
to the CNS cancer patient community, while also creating the
potential for meaningful additional upside for our investors,”
continued Sharma.
RADR® Platform Growth and Development:
- RADR®, Lantern’s AI and ML platform, continues to rapidly
expand its 25+ billion oncology-focused datapoints. Lantern expects
the platform to reach 50 billion datapoints in the coming year and
to include new datasets with an increased focus on immuno-oncology
and antibody drug conjugates. Additional advancements are
simultaneously occurring in platform automation, scalability, and
security.
- An expanded RADR® product development roadmap was recently
announced, which will enhance RADR®’s capabilities for the
development of novel and effective antibody drug conjugates (ADCs),
which are highly specific cancer-targeted antibodies linked to
potent anti-tumor small molecules. Globally, ADCs are one of the
fastest growing drug development markets and are estimated to have
a market potential of over $14 billion by 2027.
RADR® and Scientific Collaborations Update:
- Lantern recently established a new RADR® and AI-driven
collaboration with TTC Oncology to enhance the development of TTC’s
Phase 2 ready drug candidate TTC-352. TTC-352 is a novel, first-
and best-in-class selective human estrogen receptor (ER) partial
agonist (ShERPA) for the treatment of patients with metastatic ER+
breast cancer. The initial aims of the collaboration will be to
identify biomarker or gene signatures to power potential patient
selection for an upcoming TTC-352 Phase 2 clinical trial and to
discover additional treatment indications for TTC-352. Under the
terms of the collaboration, Lantern is receiving an exclusive right
to license TTC-352, including any collaboration intellectual
property (IP), during an exclusive option period.
- On March 21st, 2023 at 12:00 p.m. ET, Lantern will host a KOL
webinar on synthetic lethality, the unique mechanism of action of
Lantern’s drug candidates LP-184, LP-284, and LP-100. Synthetic
lethality can exploit vulnerabilities in cancer cells, known as DNA
damage repair deficiencies, which are estimated to be present in
25-30% of solid tumors. The webinar will feature an internationally
recognized expert in synthetic lethality, Zoltan Szallasi, M.D.,
who serves joint appointments as principal investigator at The
Danish Cancer Research Center and as assistant professor of
pediatrics at Boston Children’s Hospital, a Harvard Medical School
affiliate. Register for the webinar here.
Operational Highlights:
- Lantern has expanded its clinical leadership team with several
key additions, including Reggie Ewesuedo M.D., M.Sc., MBA, as Vice
President of Clinical Development. Combined, the new clinical
leadership team members represent over 40 years of proven success
in clinical operations and bringing drugs to market. The expansion
of the clinical development team will continue to advance the
Harmonic™ trial, as well as the upcoming first-in-human Phase 1
clinical trials for LP-184 and LP-284.
Fourth Quarter and Fiscal Year 2022 Financial
Overview:
- Balance Sheet: Cash, cash equivalents, and marketable
securities were $55.2 million as of December 31, 2022, compared to
$70.7 million as of December 31, 2021. The quarterly and annual
cash burn for 2022 reflects our capital-efficient,
collaborator-centered business model.
- R&D Expenses: Research and development expenses were
$2.3 million and $8.6 million for the quarter and year ended
December 31, 2022 compared to $2.2 million and $7.6 million for the
quarter and year ended December 31, 2021.
- G&A Expenses: General and administrative expenses
were $1.6 million and $5.8 million for the quarter and year ended
December 31, 2022, compared to $1.4 million and $5.0 million for
the quarter and year ended December 31, 2021.
- Net Loss: Net losses were $3.4 million (or $0.31 per
share) and $14.3 million (or $1.31 per share) for the quarter and
year ended December 31, 2022, compared to a net loss of $3.5
million (or $0.31 per share) and $12.4 million (or $1.13 per share)
for the quarter and year ended December 31, 2021.
Earnings Call and Webinar Details:
Lantern will host its fourth quarter and fiscal year 2022
earnings call and webinar today, Monday, March 20, 2023 at 4:30
p.m. ET.
-
https://us06web.zoom.us/webinar/register/3616775268267/WN_94qgn_1IRnuRALmciLu0CQ
- Related presentation materials will be accessible at:
https://ir.lanternpharma.com
- A replay of the fourth quarter and fiscal year 2022 earnings
call and webinar will be available at
https://ir.lanternpharma.com.
About Lantern Pharma:
Lantern Pharma (NASDAQ: LTRN) is a clinical-stage
oncology-focused biopharmaceutical company leveraging its
proprietary RADR® AI and machine learning platform to discover
biomarker signatures that identify patients most likely to respond
to its pipeline of genomically-targeted therapeutics. By targeting
drugs to patients whose genomic profile identifies them as having
the highest probability of benefiting from the drug, Lantern's
approach represents the potential to deliver best-in-class
outcomes.
Please find more information at: Website: www.lanternpharma.com
LinkedIn: https://www.linkedin.com/company/lanternpharma/ Twitter:
@lanternpharma Lantern Pharma Newsletter – The Spark: Sign-up
here
Forward-looking Statements:
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. These forward-looking statements include, among other
things, statements relating to: future events or our future
financial performance; the potential advantages of our RADR®
platform in identifying drug candidates and patient populations
that are likely to respond to a drug candidate; our strategic plans
to advance the development of our drug candidates and antibody drug
conjugate (ADC) development program; estimates regarding the
development timing for our drug candidates and ADC development
program; expectations and estimates regarding clinical trial timing
and patient enrollment; our research and development efforts of our
internal drug discovery programs and the utilization of our RADR®
platform to streamline the drug development process; our intention
to leverage artificial intelligence, machine learning and genomic
data to streamline and transform the pace, risk and cost of
oncology drug discovery and development and to identify patient
populations that would likely respond to a drug candidate;
estimates regarding patient populations, potential markets and
potential market sizes; sales estimates for our drug candidates and
our plans to discover and develop drug candidates and to maximize
their commercial potential by advancing such drug candidates
ourselves or in collaboration with others. Any statements that are
not statements of historical fact (including, without limitation,
statements that use words such as "anticipate," "believe,"
"contemplate," "could," "estimate," "expect," "intend," "seek,"
"may," "might," "plan," "potential," "predict," "project,"
"target," "model," "objective," "aim," "upcoming," "should,"
"will," "would," or the negative of these words or other similar
expressions) should be considered forward-looking statements. There
are a number of important factors that could cause our actual
results to differ materially from those indicated by the
forward-looking statements, such as (i) the impact of the COVID-19
pandemic, (ii) the risk that our research and the research of our
collaborators may not be successful, (iii) the risk that none of
our product candidates has received FDA marketing approval, and we
may not be able to successfully initiate, conduct, or conclude
clinical testing for or obtain marketing approval for our product
candidates, (iv) the risk that no drug product based on our
proprietary RADR® AI platform has received FDA marketing approval
or otherwise been incorporated into a commercial product, and (v)
those other factors set forth in the Risk Factors section in our
Annual Report on Form 10-K for the year ended December 31, 2022,
filed with the Securities and Exchange Commission on March 20,
2023. You may access our Annual Report on Form 10-K for the year
ended December 31, 2022 under the investor SEC filings tab of our
website at www.lanternpharma.com or on the SEC's website at
www.sec.gov. Given these risks and uncertainties, we can give no
assurances that our forward-looking statements will prove to be
accurate, or that any other results or events projected or
contemplated by our forward-looking statements will in fact occur,
and we caution investors not to place undue reliance on these
statements. All forward-looking statements in this press release
represent our judgment as of the date hereof, and, except as
otherwise required by law, we disclaim any obligation to update any
forward-looking statements to conform the statement to actual
results or changes in our expectations.
Lantern Pharma Disclosure Channels to Disseminate
Information:
Lantern Pharma’s investors and others should note that we
announce material information to the public about our company and
its technologies, clinical developments, licensing matters and
other matters through a variety of means, including Lantern
Pharma’s website, press releases, SEC filings, digital newsletters,
and social media, in order to achieve broad, non-exclusionary
distribution of information to the public. We encourage our
investors and others to review the information we make public in
the locations above as such information could be deemed to be
material information. Please note that this list may be updated
from time to time.
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version on businesswire.com: https://www.businesswire.com/news/home/20230320005496/en/
Nicole Leber Investor Relations Associate
ir@lanternpharma.com
Lantern Pharma (NASDAQ:LTRN)
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